Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
510(k) Number K851349
Device Name LERE NAIL & PLATE COMBIN. ONE PIECE FORGED
Applicant
Medicalex
39 Rue Croulebarbe
Paris 75013,  FR
Applicant Contact ALDO LEVY
Correspondent
Medicalex
39 Rue Croulebarbe
Paris 75013,  FR
Correspondent Contact ALDO LEVY
Regulation Number888.3030
Classification Product Code
KTW  
Date Received04/04/1985
Decision Date 05/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-